REQUEST FOR QUOTATIONS

Transcription

1 Office of Procurement 359 Blackwell Street, Suite 200 Durham, NC USA Phone: (919) REQUEST FOR QUOTATIONS Description: The USAID Global Health Supply Chain Quality Assurance Program (USAID GHSC QA) requests quotations for quality control (QC) product sampling services. RFQ Number: Date Issued: November 19, 2015 Deadline for Receipt of Quotations: 1000 Hours Eastern Time (Washington, DC) on December 16, Late offers will not be accepted. Deadline for Questions: 1400 Hours Eastern Time (Washington, DC) on December 9, Quotations must be submitted via to: Please refer to the Instructions to Offerors section beginning on page 6 for detailed instructions regarding the proposal format and submission requirements. Questions must be submitted via to: USProcurement@fhi360.org. Questions may be submitted by until 1400 Hours Eastern Time (Washington, DC) on December 9, Questions received after the deadline will not be answered. This RFQ was issued by Family Health International (FHI 360) for the USAID Global Health Supply Chain Quality Assurance Program (AID-OAA-C ).

2 CONTENTS ACRONYMS... 1 PROGRAM BACKGROUND... 2 Overview... 2 Program History... 2 New Program Design... 2 FHI DESCRIPTION OF THE RFQ... 5 Scope of Work... 5 Quote Specification... 5 Target Countries... 5 Listed Laboratories... 6 INSTRUCTIONS TO OFFERORS... 6 Quotation format and submission Procedure... 6 Technical Quotation... 8 Cost Proposal Requirements TERMS AND REQUIREMENTS Terms Requirements AWARD CRITERIA... 12

3 ACRONYMS AIDAR ARVs BP FAR FHI 360 GHI GHSC GHSC-QA IQCs ISO IUDs OI OOS PEPFAR QA QC Ph. Int. PMI RDTs RFQ RTKs RUTFs SCMS SOP USAID USG WHO USAID Acquisition Regulation Antiretroviral Drugs British Pharmacopoeia Federal Acquisition Regulation Family Health International Global Health Initiative Global Health Supply Chain Global Health Supply Chain-Quality Assurance Program Indefinite Quantity Contracts International Organization for Standardization Intrauterine Devices Opportunistic Infections Out-of-Specification U.S. President's Emergency Plan for AIDS Relief Quality Assurance Quality Control International Pharmacopoeia President s Malaria Initiative Rapid Diagnostic Tests Request for Quotation Rapid Test Kits Ready to Use Therapeutic/Supplementary Foods Supply Chain Management System Program Standard Operating Procedure U.S. Agency for International Development U.S. Government World Health Organization USAID GHSC QA Sampling RFQ 1

4 PROGRAM BACKGROUND OVERVIEW The U.S. Agency for International Development (USAID) is the U.S. Government (USG)'s principal implementing agency for international development assistance. Within USAID, the Bureau for Global Health has a broad portfolio that includes a wide array of programs and investments that represent the commitment and determination of the USG to prevent suffering, save lives, and create an environment that encourages development. Supply chain management, procurement of essential health commodities, and providing quality assurance (QA) for these commodities are essential components of the Agency's health portfolio and directly support the Agency's health contribution to the Global Health Initiative (GHI). PROGRAM HISTORY The Bureau for Global Health previously had two single-award indefinite quantity contracts (IQCs) responsible for the procurement and delivery of essential health commodities and supply chain assistance. The USAID DELIVER PROJECT focused its support largely on the President's Malaria Initiative (PMI) and programs in family planning/reproductive health, maternal and child health, emerging pandemic threats, and other areas. The Supply Chain Management System for HIV/AIDS (SCMS) IQC supported the President's Emergency Plan for AIDS Relief (PEPFAR). In 2014, USAID restructured its portfolio of projects related to health commodity procurement and QA. NEW PROGRAM DESIGN USAID consolidated the procurement and assistance elements of the USAID DELIVER PROJECT and SCMS IQCs into a single award to ensure an uninterrupted supply of essential USAID-donated health commodities, align USAID's health commodity requirements across the priority health elements, reduce costs to the USG, improve management and accountability, and ensure implementation flexibilities to respond to unpredictable global demands for USAID essential health commodities and assistance. In addition to this single award, the Bureau for Global Health issued a comprehensive QA award, the USAID Global Health Supply Chain Quality Assurance Program (USAID GHSC QA), which will promote the effectiveness and efficiency of USAID QA services by combining and coordinating QA activities across health elements. This contract will provide independent, essential, comprehensive QA and QC services covering the different health elements in the Bureau. FHI 360 was awarded a contract for the QA Program in January 2015, and under the new contract FHI 360 is charged with designing and implementing a QC strategy that provides for appropriate monitoring of the quality of health commodities procured on behalf of USAID. As product sampling is an essential element of the QC strategy, FHI 360 is releasing this RFQ to solicit quotations from qualified sampling firms to identify implementation partner(s) offering best value for sampling services to the USG. USAID GHSC QA Sampling RFQ 2

5 FHI 360 FHI 360 is a human development organization dedicated to improving lives in lasting ways through research and projects in the areas of product QA, education, health, nutrition, economic development, environment, and civil society. Since 1971, FHI 360 has worked with approximately 1,400 partners in more than 125 countries, forging strong relationships with governments, diverse organizations, the private sector, and communities. By applying science to programs, FHI 360 is helping communities make measurable progress in the areas of health, education, disease prevention, poverty alleviation, and social inequity improving lives for millions. We have the unique ability to bring a 360-degree perspective to some of the world s most complex human development challenges. We translate this perspective into customized solutions that are making a real difference in people s lives around the world. FHI 360 envisions a world in which all individuals and communities have the opportunity to reach their highest potential. Together we are helping people find their own ways of connecting with one another, with knowledge, with essential services, and with the tools they need to reach that potential. FHI 360 vision FHI 360 envisions a world in which all individuals and communities have the opportunity to reach their highest potential. FHI 360 mission FHI 360 s mission is to improve lives in lasting ways by advancing integrated, locally driven solutions for human development. FHI 360 beliefs A 360-degree perspective is required to address complex human development needs. Sustainability comes from building the capacity of individuals, communities, and countries to address their needs. The key to improving lives is in generating, sharing, and applying knowledge. Partnering with governments, civil society organizations, the private sector, and communities leads to success. USAID GHSC QA Sampling RFQ 3

6 FHI 360 values Innovation to meet the evolving needs of our beneficiaries, funders, and partners. Mutual respect for diversity and cultural differences. Passion driven by a personal commitment to make a positive difference. Accountability for our work, measuring, reporting, and continually improving all that we do. Commitment to excellence assured by the highest ethical, quality, operational performance, and scientific standards. Teamwork across disciplines and geographies, within the organization and with our partners. USAID GHSC QA Sampling RFQ 4

7 DESCRIPTION OF THE RFQ USAID GHSC QA requests responsive quotations to provide product sampling services for health commodities such as: Reproductive Health Products (Pharmaceuticals and Devices); Malaria Products (Pharmaceuticals and Long Lasting Insecticide Treated Nets); Rapid Diagnostic Test Kits (RDTs)/Rapid Test Kits (RTKs); Ready to Use Therapeutic/Supplementary Foods (RUTF); Kits for Voluntary Male Medical Circumcision; Other Laboratory Products (Point-of-Care Products); Narcotics; Essential Medicines including pharmaceutical products for HIV and Opportunistic Infections (OI). Quotations must be provided in accordance with the Instructions to Offerors. SCOPE OF WORK Services to be provided: Product sampling of all product categories listed above in accordance with prevailing standard operating procedures (SOPs) and international standards. The sampling agent will randomly select the specified number of items from each lot for sampling. Samples shall be forwarded via an international carrier to the testing laboratory specified by FHI 360. The sampling will include a report of the visual inspection and all other required activities for the specific product type being sampled. QUOTE SPECIFICATION Sampling will predominately be commodities at the manufacturing site before shipment to the final destination (pre-shipment sampling). However, sampling of commodities after arrival in country (post-shipment sampling) may be required from different locations (i.e., warehouses and central medical stores) throughout the GHSC program. Thus, quotations for both pre-shipment and post-shipment sampling are requested. The hourly and daily rates quoted shall not change during the period of performance, and expenses in excess of the quoted price will not be reimbursed. The cost quotation must be submitted using the Excel worksheet provided with the RFQ. TARGET COUNTRIES Commodities purchased through the GHSC program may come from an extensive range of countries covering North and South America, Europe, Africa, and Asia. The exact locations are yet to be determined. Due to this complexity, multiple country scenarios across all commodity types are requested for quotation as listed in the cost quotation sheet (for both pre-shipment and post-shipment examples). FHI 360 reserves the right to add or delete countries and/or additional agents from this list as needs dictate and the project progresses. USAID GHSC QA Sampling RFQ 5

8 LISTED LABORATORIES The laboratory to which the product samples will be sent will be determined by FHI 360 at the time of request. Approved laboratories may be located in a number of countries worldwide, including multiple labs in Africa, Asia, Europe, and North America. Due to this complexity, shipping costs of samples to the respective laboratories are to be excluded from the cost quotation sheet and will be negotiated prior to award. INSTRUCTIONS TO OFFERORS QUOTATION FORMAT AND SUBMISSION PROCEDURE Technical and Cost Quotations must be submitted as separate files. Both files may be transmitted in the same ; however, each file must be named and clearly labeled to identify the Offeror and quotation type (i.e., Name of Offeror-TECHNICAL, Name of Offeror-COST.). The subject line of the submission must read: Quotation for USAID GHSC-QA Program - Name of Offeror. Offerors are not expected to provide quotations for sampling all products detailed in the Cost Quotation template. Offerors should only quote the sampling services for which the organization is qualified/accredited and has relevant experience. The quotation, as well as all correspondence and documents relating to the quotation, must be in English. Intent to Participate/Not Participate Please advise FHI 360 of your receipt of the RFQ and your intent to submit or not submit a proposal by using the attached Acknowledgement Form and ing it per instructions in the document. Recipients choosing to not participate must immediately erase any versions of this RFQ. USAID GHSC QA Sampling RFQ 6

9 Quotation Due Date & Timetable Bidders quotations must be received by 10:00 EST on December 16, Please find in the table below the timetable for this RFQ process. Action Date Issue RFQ November 19, 2015 Vendor s confirmation of response Deadline for supplier questions FHI 360 response to questions Deadline for supplier RFQ responses Vendor Meetings/Follow Up; to be held remotely if needed FHI to give Supplier Feedback and Next Steps December 4, :00 EST December 9, 2015 at 12:00 EST December 11, 2015 by 12:00 EST December 16, 2015 at 10:00 EST TBD TBD This RFQ in no way obligates FHI 360 to make an award, nor does it commit FHI 360 to pay any costs incurred by the Offeror in the preparation and submission of a proposal or amendments to a proposal. USAID GHSC QA Sampling RFQ 7

10 Quotations must be organized as shown below. TECHNICAL QUOTATION Obtaining consistent information from all bidders is essential if the evaluation criteria established by FHI 360 are to be consistently and systematically applied in the assessment of all responses. Bidders are therefore required to format their submissions in accordance with the requirements outlined in this section of the document. Failure to follow these requirements may result in the rejection of the response. Technical quotations must be provided in Microsoft Word or Adobe PDF format, and must include the 10 sections listed below (in order). Each section must be numbered to match the corresponding requirement. Technical Quotations deviating from the specified format may be disqualified, and unsolicited brochures and marketing materials will not be reviewed. Section Technical Quotation Requirement 1 Brief introduction to the Offeror s organization including: Summary of experience sampling all of the products quoted Locations from which product sampling is conducted List any countries where Offeror cannot or will not work. If no countries are indicated, it will be assumed that no limitations exist. List any countries where offerors utilize subcontract staff from a secondary organization for sampling, including the appropriate subcontract contacts and credentials. 2 Evidence of accreditations or other relevant international credentials 3 Total number of staff dedicated to product sampling with an itemization of the number of staff located in specific countries, accompanied with the geographical range in which these specific staff can work 4 Expected time frame for receipt of sampling report from time of sampling. 5 Description of any relevant sampling equipment and instrumentation that may be used (type, manufacturer, quantity) 6 Detailed past performance references (maximum of 3) for health product sampling contracts/engagements including the following details for each, as applicable: Client/donor, end-user/program, period of performance (MM/YYYY MM/YYYY), and contact information including name, phone number, and address for each reference 7 Copies of any available SOPs for sampling the product types quoted USAID GHSC QA Sampling RFQ 8

11 Section Technical Quotation Requirement 8 in the past three years for each product type quoted; please use format provided below: Male Condoms Female Condoms Lubricants Injectable Contraceptives Oral Contraceptives Implants Essential Medicines, including those for HIV and OIs RDTs/RTKs, excluding Malaria RDTs RUTFs Kits for VMMC Malaria Products, including Malaria RDTs Post-Shipment Testing ; please specify nets, RDTs, and/or Malaria Pharmaceuticals 9 Year-end financial statements for the last three years 10 Legal certificate of registration 11 Required Organizational Information Vendors must indicate whether they are a public or private organization. Certificate of incorporation and by-laws DUNS (if applicable) Vendor Net Terms and Conditions USAID GHSC QA Sampling RFQ 9

12 Section Technical Quotation Requirement Tax identification number (EIN or SSN for sole proprietors) (if applicable) List of officers and Board of Directors (if incorporated) 12 Identification of any Potential Subcontractors* *Identify any potential subcontractors and submit all required information listed in Sections 9 10 for each subcontractor. COST PROPOSAL REQUIREMENTS Cost proposals must be submitted in Microsoft Excel using the attached template provided by FHI 360. Prices must be quoted in U.S. dollars ($). Offerors are not required to provide quotations for sampling all products listed in the Cost Quotation template. Offerors should only quote those services for which the organization is qualified/accredited and has relevant experience Quotations provided to FHI 360 shall be all-inclusive (i.e. staff time, travel expenses, etc.) and stated in a price per lot unit. Shipping costs for sending samples to designated labs should be excluded. Expenses in excess of the quoted price will not be reimbursed. Price per lot shall remain the same throughout the contract period. The quotation must show a separate price for each manufacturing location. USAID GHSC QA Sampling RFQ 10

13 TERMS AND REQUIREMENTS TERMS Validity Prices quoted shall remain valid for two years beyond the submission deadline for the RFQ. Award Type FHI 360 anticipates issuing purchase order(s) to the Offerer(s) determined to be the best value option(s). Work Products, Reports, and Deliverables All materials produced and delivered by the vendor and all work products will be considered work for hire and will become the property of FHI 360 and/or USAID in accordance with the USAID GHSC QA contract. Deliverables and work products produced by the vendor may be shared with third parties as required to support the Program. Offerors must be prepared to warrant that all deliverables will be free of errors and that no copyrights have been violated. Invoicing Monthly invoicing is required. Invoices must be provided in a format that is acceptable to FHI 360 and USAID. The invoicing format will be determined prior to award. Purchasing Restrictions All purchasing associated with USAID GHSC QA must comply with ADS 312 (Eligibility of Restricted Products) and 22 CFR 228 (Rules on Source and Nationality for Products and Services). Sample Terms and Conditions General terms and conditions can be accessed at the link below: FHI 360 reserves the right to add or modify terms and conditions in negotiation with any successful Offerors prior to award. REQUIREMENTS International Certifications Prospective sampling agents must provide evidence of certification to international standards, where applicable. Offerors must submit proof of current certifications. Technical Specifications The sampling services quoted and provided must fully comply with the prevailing and most applicable/appropriate standards. Source and Nationality Requirements The authorized USAID Geographic Code is 935 for this procurement. USAID GHSC QA Sampling RFQ 11

14 AWARD CRITERIA FHI 360 is not obligated to make any award by virtue of having issued this solicitation. Award is predicated on FHI 360 receiving funding for this express purpose from USAID. FHI 360 can only make an award if the quoted service fully complies with the technical specifications cited in this RFQ. FHI 360 may make an award to a single Offeror, should such an award be advantageous to USAID GHSC QA. Alternatively, FHI 360 may make awards to different Offerors, should such multiple awards be more advantageous to the Program. Quotations will be evaluated on the basis of the following criteria, in no particular order: 1. Responsiveness to the RFQ in following instructions and providing all of the required information 2. Price: Lowest evaluated price (inclusive of options quantities) provided that Offeror s technical proposal is compliant with the specifications, delivery, other requirements and terms and conditions of the RFQ 3. Qualifications and past performance 4. Delivery/turnaround time: Offeror provides the most advantageous delivery schedule for the base and option quantities USAID GHSC QA Sampling RFQ 12